Dear Curiousjeffrey,
I gatered for you the following information as per requested in your
question. Please red below and if you need anything else; just let me
know.
P.S: Would be appreciated if you rank my researched asnwer in the end.
_______________________________________________________________________________
SECTION B - SUPPLIES OR SERVICES AND PRICES/COSTS
ARTICLE B.1. BRIEF DESCRIPTION OF SUPPLIES OR SERVICES
The resultant contract will include a brief description of the work to
be performed.
ARTICLE B.2. PRICES/COSTS
The final contract will contain the price/cost provisions agreed upon
by the Government and the Offeror.
ARTICLE B.3. PROVISIONS APPLICABLE TO DIRECT COSTS
This article will prohibit or restrict the use of contract funds,
unless otherwise approved by the Contracting Officer for: 1)
Acquisition, by purchase or lease, of any interest in real property;
2) Special rearrangement or alteration of facilities; 3) Purchase or
lease of any item of general purpose office furniture or office
equipment regardless of dollar value; 4) Travel Costs; 5) Consultant
Costs; 6) Subcontract Costs; 7) Patient Care Costs; 8) Accountable
Government Property; and 9) Research Funding.
ARTICLE B.4. ADVANCE UNDERSTANDINGS
Specific elements of cost, which normally require prior written
approval of the Contracting Officer before incurrence of the cost
(e.g., foreign travel, consultant fees, subcontracts) will be included
in this Article IF the Contracting Officer has granted his/her
approval prior to contract award.
SECTION C - DESCRIPTION/SPECIFICATION/WORK STATEMENT
ARTICLE C.1. STATEMENT OF WORK
The Statement of Work will either be inserted here, or referenced as
an Attachment to the contract.
ARTICLE C.2. REPORTING REQUIREMENTS
a. Technical Progress Reports
In addition to the required reports set forth elsewhere in this
Schedule, the preparation and submission of regularly recurring
Technical Progress Reports will be required in any contract resulting
from this solicitation. These reports will require descriptive
information about the activities undertaken during the reporting
period and will require information about planned activities for
future reporting periods. The frequency and specific content of these
reports are set forth in the REPORTING REQUIREMENTS Section of the
specific RFP.
b. Summary of Salient Results
The Contractor will be required to prepare and submit, with the final
report, a summary (not to exceed 200 words) of salient results
achieved during the performance of the contract. This report will be
required on or before the expiration date of the contract.
c. Other Reports/Deliverables
The resultant contract will specify any additional reports required.
The following are examples of the type of reports that may be
required:
Note to Offeror: The following report will be required when the
contract will be for clinical research involving Human Subjects.
1. Annual Technical Progress Report for Clinical Research Study Populations
The Contractor shall submit information about the inclusion of women
and members of minority groups and their subpopulations for each study
being performed under this contract. The contractor shall submit this
information in the format indicated in the attachment entitled,
"Inclusion Enrollment Report," which is set forth in Section J of this
contract. The contractor also shall use this format, modified to
indicate that it is a final report, for reporting purposes in the
final report. The contractor shall submit the report in accordance
with ARTICLE F.1. DELIVERIES of this contract. In addition, the NIH
Policy and Guidelines on the Inclusion of Women and Minorities as
Subjects in Clinical Research, Amended, October, 2001 applies.
If this contract is for Phase III clinical trials, see II.B of these
guidelines. The Guidelines may be found at the following website:
http://grants.nih.gov/grants/funding/women_min/guidelines_amended_10_2001.htm
Include a description of the plans to conduct analyses, as
appropriate, by sex/gender and/or racial/ethnic groups in the clinical
trial protocol as approved by the IRB, and provide a description of
the progress in the conduct of these analyses, as appropriate, in the
annual progress report and the final report. If the analysis reveals
no subset differences, a brief statement to that effect, indicating
the subsets analyzed, will suffice. The Government strongly encourages
inclusion of the results of subset analysis in all publication
submissions. In the final report, the contractor shall include all
final analyses of the data on sex/gender and race/ethnicity.
Note to Offeror: The following report will be required in contracts
which contain one of the following Patent Rights Clauses: 52.227-11,
Patent Rights-Retention by the Contractor (Short Form); 52.227-11,
Patent Rights-Retention by the Contractor (Deviation); or 52.227-13,
Patent Rights-Acquisition by the Government. You may wish to check the
appropriate General Clause Listing to verify applicability.
2. Invention Reporting Requirement
All reports and documentation required by [Appropriate FAR CLAUSE will
be inserted] including, but not limited to, the invention disclosure
report, the confirmatory license, and the government support
certification, shall be directed to the Extramural Inventions and
Technology Resources Branch, OPERA, NIH, 6705 Rockledge Drive, Room
1040 A, MSC 7980, Bethesda, Maryland 20892-7980 (Telephone:
301-435-1986). In addition, one copy of an annual utilization report,
and a copy of the final invention statement, shall be submitted to the
Contracting Officer. The final invention statement (see FAR
27.303(a)(2)(ii)) shall be submitted on the expiration date of the
contract to the Contracting Officer, whose address will be identified
in the resultant contract.
If no invention is disclosed or no activity has occurred on a
previously disclosed invention during the applicable reporting period,
a negative report shall be submitted to the Contracting Officer at the
address to be provided in the resultant contract.
To assist contractors in complying with invention reporting
requirements of the clause, the NIH has developed "Interagency
Edison," an electronic invention reporting system. Use of Interagency
Edison is encouraged as it streamlines the reporting process and
greatly reduces paperwork. Access to the system is through a secure
interactive Web site to ensure that all information submitted is
protected. Interagency Edison and information relating to the
capabilities of the system can be obtained from the Web
(http://www.iedison.gov), or by contacting the Extramural Inventions
and Technology Resources Branch, OPERA, NIH.
Note to Offeror: The following report will be required when software
will be developed, modified, and/or enhanced under the resultant
contract.
3. Source Code and Object Code
Unless otherwise specified herein, the Contractor shall deliver to the
Government, upon the expiration date of the contract, all source code
and object code developed, modified, and/or enhanced under this
contract.
SECTION D - PACKAGING, MARKING AND SHIPPING
The resultant contract will insert specific requirements, if any, for
packaging, marking, and shipping of deliverables here. If specific
requirements exist, they will be described in the BACKGROUND/STATEMENT
OF WORK Section of the specific RFP. Otherwise, this section will
require that the Contractor guarantee that all required materials be
delivered in immediate, usable, and acceptable condition.
SECTION E - INSPECTION AND ACCEPTANCE
The Contracting Officer or the duly authorized representative will
inspect and accept materials and services to be delivered under the
contract. The contract will identify who will perform inspections,
where the inspections will be performed, and the time frame for
acceptance. In addition, at least one of the following clauses will be
incorporated by reference:
FAR Clause 52.246-1, CONTRACTOR INSPECTION REQUIREMENTS (APRIL 1984).
FAR Clause 52.246-2, INSPECTION OF SUPPLIES - FIXED PRICE (AUGUST 1996).
FAR Clause 52.246-3, INSPECTION OF SUPPLIES - COST-REIMBURSEMENT (MAY 2001).
FAR Clause 52.246-4, INSPECTION OF SERVICES - FIXED PRICE (AUGUST 1996).
FAR Clause 52.246-5, INSPECTION OF SERVICES-COST REIMBURSEMENT (APRIL 1984).
FAR Clause 52.246-7, INSPECTION OF RESEARCH AND DEVELOPMENT - FIXED
PRICE (AUGUST 1996).
FAR Clause 52.246-8, INSPECTION OF RESEARCH AND DEVELOPMENT - COST
REIMBURSEMENT (MAY 2001).
FAR Clause 52.246-9, INSPECTION OF RESEARCH AND DEVELOPMENT (SHORT
FORM) (APRIL 1984).
FAR Clause 52.246-16, RESPONSIBILITY FOR SUPPLIES (APRIL 1984).
If additional inspection and acceptance requirements exist, they will
be described in the BACKGROUND/STATEMENT OF WORK Section of the
specific RFP.
SECTION F - DELIVERIES OR PERFORMANCE
ARTICLE F.1. DELIVERIES
Note to Offeror: An Article containing the following information will
be included when a COMPLETION TYPE Contract will be awarded.
Satisfactory performance of the contract shall be deemed to occur upon
delivery and acceptance by the Contracting Officer, or the duly
authorized representative, of the deliverables set forth in the
REPORTING REQUIREMENTS section of the specific RFP.
The items specified for delivery will be required to be delivered
F.O.B. Destination as set forth in FAR 52.247-35, F.O.B. DESTINATION,
WITHIN CONSIGNEES PREMISES (APRIL 1984), in accordance with the
schedule to be negotiated and specified in the resultant contract and
any specifications stated in SECTION D, PACKAGING, MARKING AND
SHIPPING, of the contract.
OR
ARTICLE F.1. PERIOD OF PERFORMANCE
Note to Offeror: An Article containing the following information will
be included when a LEVEL OF EFFORT TYPE Contract will be awarded.
The period of performance of this contract shall be specified in the
contract. Additionally, the period of performance for any option
periods negotiated and anticipated will also be specified in this
Article.
ARTICLE F.2. LEVEL OF EFFORT
The level of effort agreed upon in negotiations will be specified in
the contract. The contract will also specify the criterion for
determining satisfactory performance of this requirement.
The Government's estimated Level of Effort for this RFP is set forth
in the INSTRUCTIONS, CONDITIONS AND NOTICES TO OFFERORS - Specific to
this RFP (SECTION L.I) Section of the specific RFP.
ARTICLE F. . CLAUSES INCORPORATED BY REFERENCE, FAR 52.252-2 (February 1998)
The contract awarded from this RFP will incorporate the first clause
listed below by reference, with the same force and effect as if it
were given in full text and may incorporate, as applicable and agreed
upon at negotiations one or more of the additional clauses. Upon
request, the Contracting Officer will make the full text available.
Also, the full text of a clause may be accessed electronically at this
address: http://www.arnet.gov/far/.
FEDERAL ACQUISITION REGULATION (48 CFR CHAPTER 1) CLAUSE:
52.242-15, Stop Work Order (AUGUST 1989) with ALTERNATE I (APRIL 1984).
Note to Offeror: ?ALTERNATE I (APRIL 1984)," above, will be removed in
Fixed-Price contracts.
52.242-17, Government Delay of Work (APRIL 1984).
52.211-11, Liquidated Damages--Supplies, Services or Research and
Development (APRIL 1984).
"(a) If the Contractor fails to deliver the supplies or perform the
services within the time specified in this contract, or any extension,
the Contractor shall, in place of actual damages, pay to the
Government as fixed, agreed, and liquidated damages, for each calendar
day of delay the sum of $[amount to be determined during
negotiations]."
52.247-35, F.O.B. Destination, Within Consignees Premises (APRIL 1984).
Note to Offeror: The above clause will be included here if the
resultant contract will not contain a delivery article, i.e. Level of
Effort Contract.
SECTION G - CONTRACT ADMINISTRATIVE DATA
ARTICLE G.1. PROJECT OFFICER
The Government's Project Officer(s) will be identified in the contract
The Project Officer is responsible for: (1) monitoring the
Contractor's technical progress, including the surveillance and
assessment of performance and recommending to the Contracting Officer
changes in requirements; (2) interpreting the statement of work and
any other technical performance requirements; (3) performing technical
evaluation as required; (4) performing technical inspections and
acceptances required by this contract; and (5) assisting in the
resolution of technical problems encountered during performance.
The Contracting Officer is the only person with authority to act as
agent of the Government under this contract. Only the Contracting
Officer has authority to: (1) direct or negotiate any changes in the
statement of work; (2) modify or extend the period of performance; (3)
change the delivery schedule; (4) authorize reimbursement to the
Contractor any costs incurred during the performance of this contract;
or (5) otherwise change any terms and conditions of this contract.
The Government may unilaterally change its Project Officer designation.
ARTICLE G.2. KEY PERSONNEL
Contractor personnel considered by the Government to be essential to
contract performance will be identified here. The Contracting Officer
must be notified prior to removing any of these individuals from the
contract.
ARTICLE G. . WORK ASSIGNMENT PROCEDURES
Note to Offeror: The contract will contain this article if the
BACKGROUND/STATEMENT OF WORK Section of the specific RFP indicates
that the contract will use work assignments
In providing support under this contract, the Contractor shall
initiate work only when so directed by a Work Assignment (Attachment
provided in Section J.). Approval of a Work Assignment shall not
constitute approval to exceed any item listed in the contract or
general clauses of the contract. Work Assignment amounts shall not
exceed the total amounts listed in the contract (time, dollars,
effort, consultants, travel, etc.). The Project Officer with
Contracting Officer approval, is authorized to initiate Work
Assignments and to sign Work Assignments indicating satisfactory
performance/delivery of the services/product required in each Work
Assignment. The Contractor shall assure, prior to commencing work on
any Work Assignment, that written approval of the Project Officer and
the Contracting Officer has been obtained. A Work Assignment which
does not contain both Contracting Officer and Project Officer approval
signatures shall be considered invalid and costs incurred for such
work shall be considered unallowable. The Contractor shall not exceed
the estimated labor hours, estimated Work Assignment amount, or change
the Work Assignment leader without prior written approval of the
Project Officer and the Contracting Officer by modification of the
Work Assignment. The day-to-day operational and administrative details
of the Work Assignment system will be established by the Project
Officer with input from the Contractor. The Work Assignment system
will operate within the following general guidelines:
a. Work Assignment (W.A.) Information
(1) All work to be assigned under this contract shall relate directly
to one or more of the task areas listed in the statement of work.
(2) Each W.A. shall be written for the conduct of a specific, finite task.
(3) Each new W.A. shall be numbered serially beginning with 01.
(4) Each W.A. shall be completed on the form entitled "NCI Contract
Work Assignment" and listed as an Attachment in Section J of this
contract.
(5) Upon award of the contract, an Administrative Work Assignment, as
shown in SECTION J, Attachments, shall be issued on a yearly basis.
This Work Assignment will cover the time and expenditures necessary
for the administration of the contract.
b. Initiation of a W.A.
(l) The Project Officer will initiate Part I of the W.A.
(2) The Contractor shall complete Part II and obtain the appropriate
signature. The Contractor shall forward the proposed W.A. to the
Project Officer.
(3) Upon receipt of the proposed W.A. and after determining that the
proposed W.A. is acceptable, the Project Officer will sign Part II to
indicate recommendation for approval and forward to the Contracting
Officer.
(4) Upon receipt, the Contracting Officer will review the proposed W.A.
(a) If approved, the Contracting Officer will sign Part II to indicate
approval and will forward the W.A. to the Contractor with a copy to
the Project Officer.
(b) If not approved, the Contracting Officer will notify the Project
Officer, stating the reasons for disapproval.
(5) After receipt of the approved W.A., the Contractor shall begin
work. The period of performance shall never precede the Contracting
Officer Approval date.
c. Modification to a W.A.
(1) Each amendment to an existing work assignment shall contain the
original W.A. number and shall designate a modification number.
Modification numbers for each W.A. shall be serially numbered
beginning with 01 (for example, Work Assignment 01, Modification No.
01).
(2) Each W.A. modification shall set forth in specific detail which
portion(s) of the W.A. is to be modified. All Cost/Labor modifications
shall be in the following format:
Authorized to Date This Modification Revised Estimate
Labor Hours
Cost Elements
(List Each Element)
d. Conclusion of a W.A.
(1) For each W.A. performed, the Contractor shall prepare PART III of
the W.A. for submission to the Contracting Officer.
(2) This PART III submission shall include all actual information
(cost, effort, and deliverables) relative to the W.A.
(3) PART III of the W.A. shall be submitted as soon as possible and
not to exceed three months after the closing date of the W.A. For
those Work Assignments which expire within three months prior to the
contract expiration date, PART III of the Work Assignment shall be
submitted on the final contract day.
(4) After verification that all work is complete and deliverables have
been received and accepted, the Project Officer will sign Part III of
the W.A. to indicate recommendation for approval and forward the W.A.
to the Contracting Officer.
(5) After verification that the W.A. has been satisfactorily
completed, the Contracting Officer will approve completion of the W.A.
by signing Part III of the W.A. and forward to the Contractor.
ARTICLE G. . METHOD OF ORDERING
Note to Offeror: These Articles will be included in INDEFINITE
DELIVERY Type Contracts.
The Consignees/Ordering Officials shall sign all orders (including
written confirmation of oral/telephonic orders) involving requests for
supplies and/or services under this contract. Each delivery shall be
accompanied by a packing slip or other evidence of
delivery/performance.
The authorized designees will be designated in the contract.
The contractor representative(s) authorized to receive and accept
orders placed by telephone will be designated in the contract,
ARTICLE G. . INDEFINITE DELIVERY CONTRACT PAYMENT METHOD
To initiate and receive prompt payment, the Contractor shall comply
with the following procedure:
a. A Record of Call Number or Task/Delivery Order Number shall be
given to you at the time the order is placed. The Contractor is
cautioned not to accept an order unless one of these Numbers is
issued.
b. Invoices shall be submitted monthly to the address indicated in
ARTICLE G. . INVOICE INSTRUCTIONS of this contract. Invoices shall
cite the Contract Number and the Record of Call Number or
Task/Delivery Order Number for each order for which payment is being
requested. See ARTICLE G. . INVOICE INSTRUCTIONS for more information
about submission of a proper invoice.
To record and receive the Record of Call, the Consignees/Ordering
Officials as designated in ARTICLE G. . METHOD OF ORDERING, shall
comply with the following procedure.
The Record of Call shall be entered into the Delegated Procurement
System (DELPRO) at the time the order is placed. As deliveries are
made, the receiving information shall be entered into the DELPRO
system.
ARTICLE G. . RECIPIENTS REIMBURSEMENT PROCEDURES
Note to Offeror: The contract will contain this article if the
BACKGROUND/STATEMENT OF WORK Section of the specific RFP indicates
that the contract will generate income.
a. During the course of this contract, the Contracting Officer or his
duly designated representative will notify the Contractor to make
certain shipments of [type of material will be specified in the
contract] directly to specified U.S. Government Recipients;
Contractor/Government Agencies/or other private organizations and the
Contractor shall make such shipments as directed.
b. The Contractor shall bill recipients directly for the [type of
material will be specified in the contract] provided. The charges for
these [type of material will be specified in the contract] shall be
based upon the current National Cancer Institute price list for the
items listed in an Attachment in Section J of this contract. Under no
circumstances shall the Contractor bill prices other than those listed
in the referenced price list. Prices listed are subject to change.
Revised price lists will be issued by the Government when appropriate
without the concurrence of the Contractor.
c. The Contractor shall keep an accurate account of all payments
received from recipients of [type of material will be specified in the
contract] separate from other fiscal aspects of the contract. The
Contractor shall record as credits on monthly vouchers to the
Government, all payments received from the Government Grantees,
Contractors, Government Agencies, or other private organizations. The
income from recipients must be credited to the Government in the
billing period actually received. Thus, the Contractor shall bill the
Government directly for payment of contract costs and shall subtract
as a credit all payments received from recipients. The actual
collections from sales will be offset against the gross billing
leaving a net amount due on the invoice.
The National Cancer Institute Project Officer may direct from time to
time that shipments be made entirely at Government expense.
d. The Contractor shall account for the contract related income
separately in accordance with its own double entry accounting system.
The Contractor shall submit to the Government a Monthly Summary Sheet
of Sales which is listed as an Attachment in Section J of this
contract. The Contractor shall submit a copy of this Attachment each
month with the Monthly Progress Report.
The administration of the contract related income shall be subject to
the terms of this contract, including specifically and without
limitation, the Audit--Negotiation Clause (FAR 52.215-2) of the
General Clauses, and the applicable cost principles of the Federal
Acquisition Regulation. e. The Contractor shall use the following
procedures for collection of delinquent accounts:
Step 1 - Accounts 30 days past due. A copy of the invoice shall be
sent to the recipient with a notation that the account is overdue and
request payment.
Step 2 - Accounts 60 days past due. The Contractor shall turn the
account over to a collection agency.
f. When the completion (final) invoice is submitted on this contract,
a listing of all outstanding recipient invoices shall be provided
along with details as to what disposition is expected on each.
ARTICLE G. . INVOICE SUBMISSION
Invoices will be submitted in accordance with the Invoice/Financing
Request Instructions Forms specificed in the LIST OF ATTACHMENTS
(SECTION J) of the specific RFP.
For cost-type contracts that will require a separate submission of a
separate Contract Financial Report, NIH(RC)-1, ?Invoice/Financing
Request Instructions for NIH Cost-Reimbursement Type Contracts? will
be used.
For cost-type contracts that will require the financial information
submitted along with the invoice, NIH(RC)-4, ?Invoice/Financing
Request Instructions and Contract Financial Reporting for NIH
Cost-Reimbursement Type Contracts? will be used.
For fixed-price contracts, NIH(RC)-2, ?Invoice Instruction for NIH
Fixed-Price Type Contracts? will be used.
For offerors who are under Letter of Credit, payments will be provided
in accordance with Alternate V-Advance Payments Without Special Bank
Account, of FAR Clause 52.232-12, Advance Payments, which will be
included in full text in any resultant contract.
Addresses and any additional instructions for submitting invoices will
be included in the contract.
ARTICLE G. . CONTRACT FINANCIAL REPORT
Financial reports will be submitted using the Form NIH 2706,
?Financial Report of Individual Project/Contract.? If applicable, the
NIH 2706, and the Instructions which accompany the form, will be
included in the LIST OF ATTACHMENTS (SECTION J) of the specific RFP.
Normally, reports are due quarterly. Examples of the cost elements to
be reported include:
(1) Direct Labor
(a) Principal Investigator
(b) Co-Principal Investigator
(c) Key Personnel
(2) Personnel - Other
(3) Fringe Benefits
(4) Materials/Supplies
(5) Patient Care Costs
(6) Travel
(7) Consultant Costs
(8) Subcontract Costs
(9) Other Direct Costs
(10) Indirect Costs
(11) Total Cost
(12) Fee
(13) Total Cost Plus Fixed Fee
ARTICLE G. . INDIRECT COSTS
Profit making organizations will negotiate provisional and/or final
indirect cost rates with:
Director, Division of Financial Advisory Services
Office of Acquisiton Management and Policy
National Institutes of Health
6100 Building, Room 6B05
6100 EXECUTIVE BLVD MSC 7540
BETHESDA MD 20892-7540
ARTICLE G. . GOVERNMENT PROPERTY
If this RFP will result in the acquisition or use of Government
Property provided by the contracting agency or if the Contracting
Officer authorizes in the preaward negotiation process, the
acquisition of property (other than real property), this ARTICLE will
include applicable provisions and incorporate the DHHS Publication
(OS) 686, entitled, Contractor's Guide for Control of Government
Property, (1990).
ARTICLE G. . POST AWARD EVALUATION OF CONTRACTOR PERFORMANCE
a. Contractor Performance Evaluations
Interim and final evaluations of contractor performance will be
prepared on this contract in accordance with FAR 42.15. The final
performance evaluation will be prepared at the time of completion of
work. In addition to the final evaluation, interim evaluations will be
prepared annually to coincide with the anniversary date of the
contract.
Interim and final evaluations will be provided to the Contractor as
soon as practicable after completion of the evaluation. The Contractor
will be permitted thirty days to review the document and to submit
additional information or a rebutting statement. If agreements cannot
be reached between the parties, the matter will be referred to an
individual one level above the Contracting Officer, whose decision
will be final.
Copies of the evaluations, contractor responses, and review comments,
if any, will be retained as part of the contract file, and may be used
to support future award decisions.
b. Electronic Access to Contractor Performance Evaluations
Contractors that have Internet capability may access evaluations
through a secure Web site for review and comment by completing the
registration form that can be obtained at the following address:
http://ocm.od.nih.gov/cdmp/cps_contractor.htm
The registration process requires the contractor to identify an
individual that will serve as a primary contact and who will be
authorized access to the evaluation for review and comment. In
addition, the contractor will be required to identify an alternate
contact who will be responsible for notifying the cognizant
contracting official in the event the primary contact is unavailable
to process the evaluation within the required 30-day time frame.
SECTION H - SPECIAL CONTRACT REQUIREMENTS
The following Articles may not apply to every contract. If you have
any questions about the applicability and the affect that any Article
may have on your proposal, contact the Contracting Officer Identified
on the SOLICITATION/CONTRACT FORM COVER PAGE of the specific RFP.
ARTICLE H. . HUMAN SUBJECTS
It is hereby understood and agreed that research involving human
subjects shall not be conducted under this contract, and that no
material developed, modified, or delivered by or to the Government
under this contract, or any subsequent modification of such material,
will be used by the Contractor or made available by the Contractor for
use by anyone other than the Government, for experimental or
therapeutic use involving humans without the prior written approval of
the Contracting Officer.
ARTICLE H. . HUMAN SUBJECTS
Research involving human subjects shall not be conducted under this
contract until the protocol developed in Phase I has been approved by
[to be inserted in the contract], written notice of such approval has
been provided by the Contracting Officer, and the Contractor has
provided to the Contracting Officer a properly completed "Protection
of Human Subjects Assurance Identification/IRB
Certification/Declaration of Exemption", OMB No. 0990-0263 (formerly
Optional Form 310), certifying IRB review and approval of the
protocol. The human subject certification can be met by submission of
the Contractor's self designated form, provided that it contains the
information required by the "Protection of Human Subjects Assurance
Identification/IRB Certification/Declaration of Exemption", OMB No.
0990-0263 (formerly Optional Form 310).
ARTICLE H. . REQUIRED EDUCATION IN THE PROTECTION OF HUMAN RESEARCH PARTICIPANTS
NIH policy requires education on the protection of human subject
participants for all investigators receiving NIH contract awards for
research involving human subjects. For a complete description of the
NIH Policy announcement on required education in the protection of
human subject participants, the contractor should access the NIH Guide
for Grants and Contracts Announcement dated June 5, 2000 at the
following website: http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-039.html.
The information below is a summary of the NIH Policy Announcement:
The contractor shall maintain the following information: (1) a list of
the names and titles of the principal investigator and any other
individuals working under the contract who are responsible for the
design and/or conduct of the research; (2) the title of the education
program(s) in the protection of human subjects that has been completed
for each named personnel and; (3) a one sentence description of the
educational program(s) listed in (2) above. This requirement extends
to investigators and all individuals responsible for the design and/or
conduct of the research who are working as subcontractors or
consultants under the contract.
Prior to any substitution of the Principal Investigator or any other
individuals responsible for the design and/or conduct of the research
under the contract, the contractor shall provide the following written
information to the Contracting Officer: the title of the education
program and a one sentence description of the program that has been
completed by the replacement.
ARTICLE H. . DATA AND SAFETY MONITORING IN CLINICAL TRIALS
The contractor is directed to the full text of the NIH Policy
regarding Data and Safety Monitoring and Reporting of Adverse Events,
which may be found at the following web sites:
http://grants.nih.gov/grants/guide/notice-files/not98-084.html
http://grants.nih.gov/grants/guide/notice-files/not99-107.html
http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-038.html
The contractor must comply with the NIH Policy cited in these NIH
Announcements and any other data and safety monitoring requirements
found elsewhere in this contract.
Data and Safety Monitoring shall be performed in accordance with the
approved Data and Safety Monitoring Plan.
The Data and Safety Monitoring [BOARD and PLAN] shall be established
and approved prior to beginning the conduct of the clinical trial.
ARTICLE H. . HIV ANTIRETROVIRAL TREATMENT TRIALS
Note to Offeror: The following Article will be included in any
contract for HIV Antiretroviral Treatment Trials that will take place
in whole or in part in Developing Countries--Defined as the Low- and
Middle-Income economies, using World Bank Classifications - AND - the
Offeror planned to develop sources to provide treatment of trial
participants after their completion of the trial.
The contractor shall work with the host countries? authorities and
other stakeholders in accordance with the approved plan to develop
sources to provide HIV antiretroviral treatment to participants of the
trials contracted for under this contract after the participants?
completion of the trial.
ARTICLE H. . HUMAN MATERIALS
The acquisition and supply of all human specimen material (including
fetal material) used under this contract shall be obtained by the
Contractor in full compliance with applicable State and Local laws and
the provisions of the Uniform Anatomical Gift Act in the United
States, and no undue inducements, monetary or otherwise, will be
offered to any person to influence their donation of human material.
ARTICLE H. . HUMAN MATERIALS (ASSURANCE OF OHRP COMPLIANCE)
The acquisition and supply of all human specimen material (including
fetal material) used under this contract shall be obtained by the
Contractor in full compliance with applicable State and Local laws and
the provisions of the Uniform Anatomical Gift Act in the United
States, and no undue inducements, monetary or otherwise, will be
offered to any person to influence their donation of human material.
The Contractor shall provide written documentation that all human
materials obtained as a result of research involving human subjects
conducted under this contract, by collaborating sites, or by
subcontractors identified under this contract, were obtained with
prior approval by the Office for Human Research Protections (OHRP) of
an Assurance to comply with the requirements of 45 CFR 46 to protect
human research subjects. This restriction applies to all collaborating
sites without OHRP-approved Assurances, whether domestic or foreign,
and compliance must be ensured by the Contractor.
Provision by the Contractor to the Contracting Officer of a properly
completed "Protection of Human Subjects Assurance Identification/IRB
Certification/Declaration of Exemption", OMB No. 0990-0263 (formerly
Optional Form 310), certifying IRB review and approval of the protocol
from which the human materials were obtained constitutes the written
documentation required. The human subject certification can be met by
submission of a self designated form, provided that it contains the
information required by the "Protection of Human Subjects Assurance
Identification/IRB Certification/Declaration of Exemption", OMB No.
0990-0263 (formerly Optional Form 310).
ARTICLE H. . RESEARCH INVOLVING HUMAN FETAL TISSUE
All research involving human fetal tissue shall be in conducted in
accordance with the Public Health Service Act, 42 U.S.C. 289g-1 and
289g-2. Implementing regulations and guidance for conducting research
on human fetal tissue may be found at 45 CFR 46, Subpart B and
http://grants1.nih.gov/grants/guide/notice-files/not93-235.html and
any subsequent revisions to this NIH Guide to Grants and Contracts
("Guide") Notice.
The contractor shall make available, for audit by the Secretary, DHHS,
the physician statements and informed consents required by 42 USC
289g-1(b) and (c), or ensure DHHS access to those records, if
maintained by an entity other than the contractor.
ARTICLE H. . RESEARCH INVOLVING RECOMBINANT DNA MOLECULES (Including
Human Gene Transfer Research)
All research involving Recombinant DNA Molecules shall be conducted in
accordance with the NIH Guidelines for Research Involving Recombinant
DNA Molecules (http://www4.od.nih.gov/oba/rac/guidelines/guidelines.html)
and the May 28, 2002 Notice, Compliance with the NIH Guidelines for
Research Involving Recombinant DNA Molecules
(http://grants1.nih.gov/grants/guide/notice-files/NOT-OD-02-052.html)
(and any subsequent revisions to the Guide Notice) which stipulates
biosafety and containment measures for recombinant DNA research and
delineates critical, ethical principles and key safety reporting
requirements for human gene transfer research (See Appendix M of the
Guidelines). These guidelines apply to both basic and clinical
research studies.
The Recombinant DNA Advisory Committee (RAC) is charged with the
safety of manipulation of genetic material through the use of
recombinant DNA techniques. Prior to beginning any clinical trials
involving the transfer of recombinant DNA to humans, the trial must be
registered with the RAC. If this contract involves new protocols that
contain unique and//or novel issues, the RAC must discuss them in a
public forum and then the Institutional Biosafety Committee (IBC), the
Institutional Review Board (IRB), and the project officer and
contracting officer must approve the protocol prior to the start of
the research.
Failure to comply with these requirements may result in suspension,
limitation, or termination of the contract for any work related to
Recombinant DNA Research or a requirement for contracting officer
prior approval of any or all Recombinant DNA projects under this
contract. This includes the requirements of the Standing Institutional
Biosafety Committee (IBC) (See
http://www4.od.nih.gov/oba/IBC/IBCindexpg.htm).
As specified in Appendix M-1-C-4 of the NIH Guidelines, any serious
adverse event must be reported immediately to the IRB, the IBC, the
Office for Human Research Protections (if applicable), and the NIH
Office for Biotechnology Activities (OBA), followed by the filing of a
written report with each office/group and copies to the project
officer and contracting officer.
(http://www4.od.nih.gov/oba/rac/guidelines_02/Appendix_M.htm#_Toc7255836).
ARTICLE H. . HUMAN EMBRYONIC GERM CELL (HEGC) RESEARCH
All HPSCRUG (Human Pluripotent Stem Cell Review Group) approved
research involving human embryonic germ cells shall be conducted in
accordance with the NIH Guidelines for Research Using Human
Pluripotent Stem Cells
(http://stemcells.nih.gov/policy/guidelines.asp)
ARTICLE H. . HUMAN EMBRYONIC GERM CELL (HEGC) RESEARCH
Federally funded research involving the use of human embryonic germ
cells derived from fetal tissue shall not be conducted under this
contract until Human Pluripotent Stem Cell Review Group (HPSCRG)
review and approval has been obtained. Once approved by the HPSCRG,
all research shall be conducted in accordance with the NIH Guidelines
for Research Using Human Pluripotent Stem Cells
(http://stemcells.nih.gov/policy/guidelines.asp).
Note to Offeror: The following or similar language to reflect the
specifics of the contract, when contract award has been made prior to
review and approval of the HPSCRG will be included in any contract
resulting from this solicitation.
Phase(s)/Option Period(s) ___________which require(s) research
involving the use of human embryonic germ cells shall not be conducted
under this contract until the HPSCRG review and approval have been
obtained, and documented by written notice of such approval by the
contracting officer. If the HPSCRG disapproves the documentation
presented by the contractor, [the contract may be terminated in
accordance with the Termination of Convenience Clause referenced in
Article I.1. of this contract/ OR the Contracting Officer may elect
not to exercise Option(s) _________ of this contract in accordance
with the Option Clause referenced in Article I.3. of this contract.]
In addition, it may be necessary for the Contracting Officer to invoke
FAR Clause 52.242-15, Stop Work Order, referenced in Article F. .
Clauses Incorporated by Reference, of this contract if the review and
approval process cannot be accomplished in a time frame that allows
for continuity of this research effort.
ARTICLE H. . HUMAN EMBRYONIC STEM CELL (HESC) RESEARCH
All research conducted under this contract shall involve the use of
existing human embryonic stem cells established under the NIH
Embryonic Stem Cell Registry only.
ARTICLE H. . CONTINUED BAN OF FUNDING OF HUMAN EMBRYO RESEARCH
a. Pursuant to Public Law(s) cited in paragraph b. , below, NIH is
prohibited from using appropriated funds to support human embryo
research. Contract funds may not be used for (1) the creation of a
human embryo or embryos for research purposes; or (2) research in
which a human embryo or embryos are destroyed, discarded, or knowingly
subjected to risk of injury or death greater than that allowed for
research on fetuses in utero under 45 CFR 46.208(a)(2) and Section
498(b) of the Public Health Service Act (42 U.S.C. 289g(b)). The term
"human embryo or embryos" includes any organism, not protected as a
human subject under 45 CFR 46 as of the date of the enactment of this
Act, that is derived by fertilization, parthenogenesis, cloning, or
any other means from one or more human gametes or human diploid cells.
Additionally, in accordance with a March 4, 1997 Presidential
Memorandum, Federal funds may not be used for cloning of human beings.
b. Public Law and Section No. Fiscal Year Period Covered
[applicable information to be included at award]
ARTICLE H. . NEEDLE EXCHANGE
a. Pursuant to Public Law(s) cited in paragraph b., below, contract
funds shall not be used to carry out any program of distributing
sterile needles or syringes for the hypodermic injection of any
illegal drug.
b. Public Law and Section No. Fiscal Year Period Covered
[applicable information to be included at award]
ARTICLE H. . PRIVACY ACT
This procurement action requires the Contractor to do one or more of
the following: design, develop, or operate a system of records on
individuals to accomplish an agency function in accordance with the
Privacy Act of 1974, Public Law 93-579, December 31, 1974 (5 USC 552a)
and applicable agency regulations. Violation of the Act may involve
the imposition of criminal penalties.
The Privacy Act System of Records applicable to this project is Number
[to be included in contract]. This document is incorporated into this
contract as an Attachment in SECTION J of the contract.
ARTICLE H. . EVALUATION PROJECTS
All publications including reports, compilations of data, articles and
the like resulting from this contract shall contain the statement
below. It shall be located on the cover, inside cover, or title page.
This project [NIH EVALUATION PROJECT NUMBER AND CONTRACT NUMBER will
be inserted] received support from the evaluation set-aside Section
513, Public Health Service Act.
ARTICLE H. . ANIMAL WELFARE
All research involving live, vertebrate animals shall be conducted in
accordance with the Public Health Service Policy on Humane Care and
Use of Laboratory Animals. This policy may be accessed at
http://grants1.nih.gov/grants/olaw/references/phspol.htm
ARTICLE H. . INTRODUCTION OF RODENTS AND RODENT PRODUCTS
No rodent or rodent product shall be delivered into the NIH, NCI
environment (NIH) directly, or through collaborative research or
holding facilities under contract to NCI except by permit. Direct
shipments to NIH from a Division of Veterinary Resources (DVR), Office
of Research Services (ORS) approved source will be considered exempt.
Non-exempt sources must be approved by permit issued through the DVR,
ORS. The permit must be obtained by the Contractor prior to the
shipment to NIH of the rodents and/or rodent products. The Contractor
must be sure that this permit exists and is current before
transferring rodents or rodent products into the NIH, NCI environment.
Refusal or negligence to do so will be considered a material breach of
contract and may be treated as any other such material breach.
Applications for permits should be submitted by facsimile not less
than 30 days prior (60 days in situations where quarantine is likely)
to shipping date to: NIH Division of Veterinary Resources (DVR),
Office of Research Services (ORS), Building 14G, Service Rd. South,
Room 102, BETHESDA MD 20892-5210, (301)496-2527, FAX: (301) 402-0352.
ARTICLE H. . OMB CLEARANCE
In accordance with HHSAR 352.270-7, Paperwork Reduction Act, the
Contractor shall not proceed with surveys or interviews until such
time as Office of Management and Budget (OMB) Clearance for conducting
interviews has been obtained by the Project Officer and the
Contracting Officer has issued written approval to proceed.
ARTICLE H. . OPTION PROVISION
Unless the Government exercises its option pursuant to the Option
Clause set forth in ARTICLE I.3., the contract will consist only of
(the base period, Phase I, or Year I) set forth in the Statement of
Work as defined in Sections C and F of the contract. Pursuant to
clause 52.217-* set forth in ARTICLE I.3. of this contract, the
Government may, by unilateral contract modification, require the
Contractor to perform (Phases(s) or Year(s) ) of the Statement of Work
as also defined in Sections C and F of this contract. If the
Government exercises this option, notice must be given at least 60
days prior to the expiration date of this contract, and the estimated
cost [plus fixed fee] of the contract will be increased as set forth
in Article B.3.
*Clause number will be determined during negotiations.
Note to Offeror: If Options are applicable, the specific RFP shall
identify all necessary information about options including
requirements for proposal preparation, if any, and the evaluation of
options.
ARTICLE H. . SUBCONTRACTING PROVISIONS
a. Small Business Subcontracting Plan
(1) The Small Business Subcontracting Plan, dated is attached hereto
and made a part of this contract.
(2) The failure of any Contractor or subcontractor to comply in good
faith with FAR Clause 52.219-8, entitled "Utilization of Small
Business Concerns" incorporated in this contract and the attached
Subcontracting Plan, will be a material breach of such contract or
subcontract and subject to the remedies reserved to the Government
under FAR Clause 52.219-16 entitled, "Liquidated
Damages-Subcontracting Plan."
b. Subcontracting Reports
(1) Subcontracting Report for Individual Contracts, SF-294
The Contractor shall submit the original and one (1) copy of
Subcontracting Report for Individual Contracts, SF-294 in accordance
with the instructions on the report as referenced in Public Law
95-507, Section 211. In addition to the information contained in the
General Instructions on the back of this form for Block 17, "Remarks,"
the Contractor shall provide an explanation for any category of small
business subcontracting for which there were no dollars reported since
the last reporting period.
Regardless of the effective date of this contract, the Report shall be
submitted on the following dates for the entire life of this contract:
April 30th
October 30th
The Report shall be sent to the following address:
Contracting Officer
Research Contracts Branch
National Cancer Institute, NIH
EPS, Room
6120 EXECUTIVE BLVD MSC
BETHESDA MD 20892-
(2) Summary Subcontract Report, SF-295
The Contractor shall submit two (2) copies of Summary Subcontract
Report, SF-295 in accordance with the instructions on the report as
referenced in Public Law 95-507, Section 211. Regardless of the
effective date of this contract, the Summary Subcontract Report shall
be submitted annually on the following date for the entire life of
this contract:
October 30th
One copy of this report shall be sent to the Contracting Officer at
the address above. One copy of this Report shall be mailed to the
Office of Small and Disadvantaged Business Utilization, DHHS at
following address:
Office of Small and Disadvantaged Business Utilization
Department of Health and Human Services
Hubert H. Humphrey Bldg., Room 360G
200 Independence Avenue, S.W.
Washington, D.C. 20201
(3) The contractor shall also send an "Information Copy" of the SF-295
to the Cognizant Commercial Representative (CMR) at the address
provided by the SBA. The Contractor should call SBA Headquarters in
Washington, DC at (202) 690-7235, for the correct address if unknown.
ARTICLE H. . SALARY RATE LIMITATION LEGISLATION PROVISIONS
a. Pursuant to Public Law(s) cited in paragraph b., below, no NIH
Fiscal Year funds may be used to pay the direct salary of an
individual through this contract at a rate in excess of applicable
amount shown for the fiscal year covered. Direct salary is exclusive
of fringe benefits, overhead, and general and administrative expenses
(also referred to as "indirect cost" or "facilities and administrative
(F&A) costs"). Direct salary has the same meaning as the term
"institutional base salary." An individual's direct salary (or
institutional base salary) is the annual compensation that the
contractor pays for an individual's appointment whether that
individual's time is spent on research, teaching, patient care or
other activities. Direct salary (or institutional base salary)
excludes any income that an infividual may be permitted to earn
outside of duties to the contractor. The per year salary rate limit
also applies to individuals proposed under subcontracts. If this is a
multiple year contract, it may be subject to unilateral modifications
by the Government if an individual's salary rate exceeds any salary
rate ceiling established in future DHHS appropriation acts.
b. Public Law and Section No. Fiscal Year Dollar Amount of Salary Limitation*
[applicable information to be included at award]
* Currently this amount is $[to be inserted in contract] and will
remain at this level until such time as the Executive Level I is
increased. See the following web site for Executive Schedule rates of
pay:
FOR FY05 EXECUTIVE LEVEL SALARIES EFFECTIVE JANUARY 1, 2005:
http://www.opm.gov/oca/05tables/html/ex.asp
(NOTE: This site shows the CY 05 rates. For previous years, click on
?salaries and wages? and then scroll down to the bottom of the page
and click on the year to locate the desired Executive Level salary
rates).
ARTICLE H. . INFORMATION TECHNOLOGY SYSTEMS SECURITY SPECIFICATIONS
The contractor shall comply with all Federal computer and Information
Technology (IT) systems security and/or privacy rules, regulations and
specifications. Some of the relevant regulations and policies include
but are not limited to:
Computer Security Act of 1987: http://csrc.nist.gov/ispab/csa_87.txt
OMB A-130, Appendix III, ?Security of Federal Automated Information
Systems:? http://csrc.nist.gov/policies/appendix_iii.pdf
DHHS Information Security Program Policy:
http://www.hhs.gov/read/irmpolicy/FINALHHSInformationSecurityProgramP.doc
OMB Circular A-130 memorandum M-03-22, ?OMB Guidance for Implementing
the Privacy Provisions of the E-Government Act of 2002:?
http://www.whitehouse.gov/omb/memoranda/m03-22.html
OMB Memorandum M-05-04 (12/04):
http://www.whitehouse.gov/omb/memoranda/fy2005/m05-04.pdf
The contractor shall include this provision in any subcontract awarded
pursuant to this prime contract. Failure to comply with these
requirements shall constitute cause for termination.
The contractor shall protect all information used, gathered, or
developed as a result of the Statement of Work (SOW). The contractor
shall establish and implement appropriate administrative, technical,
and physical safeguards to ensure the security and confidentiality of
sensitive Government information, data, and/or equipment.
NOTE to Offeror: If the Statement of Work requires the contractor to
host government data, web sites, applications, or domain names, the
following paragraph will be added.
The contractor shall prepare and submit a Vulnerability Assessments
and Remediation Report on a monthly basis. This report shall be
submitted to: NCI, ISSO, 6116 Executive Blvd, Suite 501, Rockville, MD
20852-8340 [and PROJECT OFFICER as appropriate.
In addition, during all activities and operations on Government
premises, or activities and operations involving government data,
computers or networks, the contractor shall comply with all DHHS and
National Institutes of Health (NIH), policies and rules of conduct.
Procedural guidance for compliance with the following requirements can
be found at the following website: http://ais.nci.nih.gov.
a. Required IT Systems Security Training
The contractor shall assure that each employee has completed the NIH
Computer Security Awareness Training (http://irtsectraining.nih.gov/)
prior to performing any work under this contract.
The contractor shall maintain a listing by name and title of each
individual working under this contract who has completed the NIH
required training. Any additional security training completed by
contractor staff shall be included on this listing. [The listing of
completed training shall be included in the first technical progress
report. (See Article C.2. Reporting Requirements) Any revisions to
this listing as a result of staffing changes shall be submitted with
next required technical progress report.]
As indicated in OMB Circular A-130 and/or NIST Special Publication
800-16, "Information Technology Security Training Requirements,"
contractor staff shall complete the following additional training
prior to performing any work under this contract:
[If applicable, required training courses will be listed here.]
b. Position Sensitivity Designations
(1) The Government has determined that the following position
sensitivity designations and associated clearance and investigation
requirements apply under this contract:
Note to Offeror: The specific RFP will provide information about teh
Position Sensitivity Designations. The following general information
is provided as an example of the possible designations that may be
included in the resultant contract.
Level 6C: Sensitive - High Risk (Requires Suitability Determination with a BI).
Contractor employees assigned to a Level 6C position are subject to a
Background Investigation (BI).
Level 5C: Moderate Risk (Requires Suitability Determination with
NACIC, MBI or LBI). Contractor employees assigned to a Level 5C
position with no previous investigation and approval shall undergo a
National Agency Check and Inquiry Investigation plus a Credit Check
(NACIC), a Minimum Background Investigation (MBI), or possibly a
Limited Background Investigation (LBI).
Level 1C: Non Sensitive (Requires Suitability Determination with an NACI).
Contractor employees assigned to a Level 1C position are subject to a
National Agency Check and Inquiry Investigation (NACI).
Note to Offeror: Applicable Position Titles may be included for each
designation if considered appropriate.
(2) The contractor shall submit a roster, by name, position and
responsibility, of all IT staff working under the contract. The roster
shall be submitted to the Project Officer, with a copy to the
Contracting Officer, within 14 days of the effective date of the
contract. The Contracting Officer shall notify the contractor of the
appropriate level of suitability investigations to be performed. An
electronic template, entitled ?Roster of Employees Requiring
Suitability Investigations,? is available for use at
http://virtual.nci.nih.gov/security/policy/aissp/contractor/forms/Suitability-roster.xls
Upon receipt of the Government?s notification of applicable
Suitability Investigation required, the contractor shall complete and
submit the required forms within 30 days of the notification.
Additional submission instructions can be found at:
http://ais.nci.nih.gov/.
Contractor employees who have had a background investigation conducted
by the U.S. Office of Personnel Management (OPM) withing the last five
years may only require an updated or upgraded investigation.
(3) Contractor employees in AIS-related positions shall comply with
the DHHS criteria for the assigned position sensitivity designations
prior to performing any work under this contract. The following
exceptions apply:
Levels 5C and 1C: Contractor employees may begin work under the
contract after the contractor has submitted the name, positition and
responsibility of the employee to the Project Officer, as described in
paragraph b(2) above.
Levels 6C: In special circumstances the Project Officer may request a
waiver of the preappointment investigation. If the waiver is granted,
the Project Officer will provide written authorization for the
contractor employee to work under the contract.
c. Personnel Security Responsibilities
The contractor shall perform and document the following when a
contractor employee terminates work under this contract. All
documentation shall be made available to the Project Officer and/or
Contracting Officer upon request:
(1) Employment terminated
Confirm that the contractor employee either completed all assigned
tasks or briefed the replacement employee on the requirements and
status of ongoing tasks.
Determine the contractor employee?s access termination date, and
notify the Project Officer, appropriate NIH security officials, and
the assigned IT Systems Manager within 24 hours of the time of
termination..
Request the assigned IT Systems Manager to terminate the contractor
employee?s access authorizations.
Review with the contractor employee his/her obligations to protect
agency information accessed while working under this contract.
Immediately revoke the employee?s access to all Government systems and
data and notify the Project Officer in writing upon completion of
these actions.
(2) Contractor Employee is removed from contract for cause:
Physically remove the contractor employee from working under this contract.
Immediately notify the Project Officer, appropriate NIH security
officials, and the assigned IT Systems Manager of the time of removal.
Request an immediate revocation of the contractor employee?s access
authorizations.
Retrieve all keys and badges.
Request the Project Officer to have the combinations changed on all
locks to which the contractor employee had access.
Review the contractor employee?s duties and responsibilities under
this contract with the Project Officer and assess the level of risk to
the Government.
Immediately revoke the employee?s access to all Government systems and
data and notify the Project Officer in writing upon completion of
these actions.
d. Commitment to Protect Sensitive Information
(1) Contractor Agreement
The Contractor shall not release, publish, or disclose sensitive
information to unauthorized personnel, and shall protect such
information in accordance with provisions of the following laws and
any other pertinent laws and regulations governing the confidentiality
of sensitive information:
-18 U.S.C. 641 (Criminal Code: Public Money, Property or Records)
-18 U.S.C. 1905 (Criminal Code: Disclosure of Confidential Information)
-Public Law 96-511 (Paperwork Reduction Act)
(2) Contractor-Employee Non-Disclosure Agreements
Each contractor employee who may have access to sensitive information
under this contract shall complete the attachment entitled,
?Commitment To Protect Non-Public Information - Contractor Agreement,?
which is referenced in Section J of this contract and available at:
http://irm.cit.nih.gov/security/Nondisclosure.pdf
A copy of each signed and witnessed Non-Disclosure agreement shall be
submitted to the Project Officer prior to performing any work under
the contract.
ARTICLE H. . ELECTRONIC AND INFORMATION TECHNOLOGY STANDARDS
Pursuant to Section 508 of the Rehabilitation Act of 1973 (29 U.S.C.
794d) as amended by P.L.105-220 under Title IV (Rehabilitation Act
Amendments of 1998) all Electronic and Information Technology (EIT)
developed, procured, maintained and/or used under this contract shall
be in compliance with the "Electronic and Information Technology
Accessibility Standards" set forth by the Architectural and
Transportation Barriers Compliance Board (also referred to as the
"Access Board") in 36 CFR Part 1194. The complete text of Section 508
Final Standards can be accessed at http://www.access-board.gov/
The standards applicable to this requirement are [identified in the
BACKGROUND/STATEMENT OF WORK Section of the specific RFP]:
ARTICLE H. . ENERGY STAR REQUIREMENTS
Executive Order 13123, "Greening the Government Through Efficient
Energy Management" and FAR 23.203 require that when Federal Agencies
acquire energy using products, they select, where life-cycle
cost-effective, and available, ENERGY STARŪ or other energy efficient
products.
Unless the Contracting Officer determines otherwise, all energy-using
products acquired under this contract must be either an ENERGY STARŪ
or other energy efficient product designated by the Department of
Energy's Federal Energy Management Program (FEMP).
For more information about ENERGY STARŪ see http://www.energystar.gov/
For more information about FEMP see http://www.eere.energy.gov/
ARTICLE H. . ACCESS TO NATIONAL INSTITUTES OF HEALTH (NIH) ELECTRONIC MAIL
[Note to Offeror: The following Article will be included in any
contract where the possibility exists that the resultant contractor
will have access to NIH e-mail.]
All Contractor staff that have access to and use of NIH electronic
mail (e-mail) must identify themselves as contractors on all outgoing
e-mail messages, including those that are sent in reply or are
forwarded to another user. To best comply with this requirement, the
contractor staff shall set up an e-mail signature ("AutoSignature") or
an electronic business card ("V-card") on each contractor employee's
computer system and/or Personal Digital Assistant (PDA) that will
automatically display "Contractor" in the signature area of all
e-mails sent.
ARTICLE H. . CONFIDENTIALTIY OF INFORMATION
The following information is covered by HHSAR 352.224-70,
Confidentiality of Information (MARCH 2005):
[The specific information applicable to this clause will be included
in the contract]
ARTICLE H. . PUBLICATION AND PUBLICITY
The contractor shall acknowledge the support of the National
Institutes of Health whenever publicizing the work under this contract
in any media by including an acknowledgment substantially as follows:
"This project has been funded in whole or in part with Federal funds
from the National Cancer Institute, National Institutes of Health,
Department of Health and Human Services under Contract No. [contract
number will be inserted].
ARTICLE H. . PRESS RELEASES
a. Pursuant to Public Law(s) cited in paragraph b., below, the
contractor shall clearly state, when issuing statements, press
releases, requests for proposals, bid solicitations and other
documents describing projects or programs funded in whole or in part
with Federal money: (1) the percentage of the total costs of the
program or project which will be financed with Federal money; (2) the
dollar amount of Federal funds for the project or program; and (3) the
percentage and dollar amount of the total costs of the project or
program that will be financed by nongovernmental sources.
b. Public Law and Section No. Fiscal Year Period Covered
[applicable information to be included at award]
ARTICLE H. . TASK ORDER/DELIVERY ORDER CONTRACT OMBUDSMAN
In accordance with FAR 16.505(b)(5), the following individual has been
designated as the NIH Ombudsman for task order and delivery order
contracts.
[The appropriate individual will be included in the resultant contractas follows:]
For R&D Contracts:
Dr. Walter Schaffer
NIH Competition Advocate
6705 Rockledge Drive, Room 3537
Bethesda, MD 20817
Phone: (301) 435-2687
FAX: (301) 480-0146
e-mail: schaffew@od.nih.gov
For Non R&D Contracts:
Philip S. Chan, Jr. Ph.D
NIH Competition Advocate
1 Center Drive, Room 140
Bethesda, MD 20892
Phone: (301) 496-3561
FAX: (301) 402-0027
e-mail: pchen@box-p.nih.gov
ARTICLE H. . REPORTING MATTERS INVOLVING FRAUD, WASTE, AND ABUSE
Anyone who becomes aware of the existence or apparent existence of
fraud, waste and abuse in NIH funded programs is encouraged to report
such matters to the HHS Inspector General's Office in writing or on
the Inspector General's Hotline. The toll free number is
1-800-HHS-TIPS (1-800-447-8477). All telephone calls will be handled
confidentially. The e-mail address is Htips@os.dhhs.gov and the
mailing address is:
Office of Inspector General
Department of Health and Human Services
TIPS HOTLINE
P.O. Box 23489
Washington, D.C. 20026
ARTICLE H. . YEAR 2000 COMPLIANCE
In accordance with FAR 39.106, Information Technology acquired under
this contract must be Year 2000 compliant as set forth in the
following clause(s):
1. Service Involving the Use of Information Technology
YEAR 2000 COMPLIANCE--SERVICE INVOLVING THE USE OF INFORMATION TECHNOLOGY
The Contractor agrees that each item of hardware, software, and
firmware used under this contract shall be able to accurately process
date data (including, but not limited to, calculating, comparing and
sequencing) from, into and between the twentieth and twenty-first
centuries and the Year 1999 and the Year 2000 and leap year
calculations.
(End of Clause)
2. Noncommercial Supply Items Warranty
YEAR 2000 WARRANTY--NONCOMMERCIAL SUPPLY ITEMS
The contractor warrants that each noncommercial item of hardware,
software, and firmware delivered or developed under this contract and
listed below shall be able to accurately process date data (including,
but not limited to, calculating, comparing and sequencing) from, into
and between the twentieth and twenty-first centuries and the Year 1999
and the Year 2000 and leap year calculations, when used in accordance
with the item documentation provided by the contractor, provided that
all listed or unlisted items (e.g., hardware, software and firmware)
used in combination with such listed item properly exchange date data
with it. If the contract requires that specific listed items must
perform as a system in accordance with the foregoing warranty, then
that warranty shall apply to those listed items as a system. The
duration of this warranty and the remedies available to the Government
for breach of this warranty shall be as defined in, and subject to,
the terms and limitations of any general warranty provisions of this
contract provided that notwithstanding any provision to the contrary
in such warranty provision(s), or in the absence of any such warranty
provision(s), the remedies available to the Government under this
warranty shall include repair or replacement of any listed item whose
noncompliance is discovered and made known to the contractor in
writing within ninety (90) days after acceptance. Nothing in this
warranty shall be construed to limit any rights or remedies the
Government may otherwise have under this contract with respect to
defects other than Year 2000 performance.
LIST YEAR 2000 COMPLIANT ITEMS:
(end of clause)
3. Commercial Supply Products Warranty
YEAR 2000 WARRANTY--COMMERCIAL SUPPLY ITEMS
The contractor warrants that each hardware, software and firmware
product delivered under this contract and listed below shall be able
to accurately process date data (including, but not limited to,
calculating, comparing, and sequencing) from, into, and between the
twentieth and twenty-first centuries and the Year 1999 and the Year
2000 and leap year calculations, when used in accordance with the
product documentation provided by the contractor, provided that all
listed or unlisted products (e.g., hardware, software, firmware) used
in combination with such listed product properly exchange date data
with it. If the contract requires that specific listed products must
perform as a system in accordance with the foregoing warranty, then
that warranty shall apply to those listed products as a system. The
duration of this warranty and the remedies available to the Government
for breach of this warranty shall be as defined in, and subject to,
the terms and limitations of the contractor's standard commercial
warranty or warranties contained in this contract, provided that
notwithstanding any provision to the contrary in such commercial
warranty or warranties, the remedies available to the Government under
this warranty shall include repair or replacement of any listed
product whose non-compliance is discovered and made known to the
contractor in writing within ninety (90) days after acceptance.
Nothing in this warranty shall be construed to limit any rights or
remedies the Government may otherwise have under this contract with
respect to defects other than Year 2000 performance.
LIST YEAR 2000 COMPLIANT ITEMS:
(end of clause)
ARTICLE H. . ANTI-LOBBYING
a. Pursuant to Public Law(s) cited in paragraph c., below, contract
funds shall only be used for normal and recognized
executive-legislative relationships. Contract funds shall not be used
for publicity or propaganda purposes; or for the preparation,
distribution, or use of any kit, pamphlet, booklet, publication,
radio, television, or video presentation designed to support or defeat
legislation pending before the Congress or any State legislature,
except in presentation to the Congress or any State legislature
itself.
b. Contract funds shall not be used to pay salary or expenses of the
contractor or any agent acting for the contractor, related to any
activity designed to influence legislation or appropriations pending
before the Congress or any State legislature.
c. Public Law and Section No. Fiscal Year Period Covered
[applicable information to be included at award]
ARTICLE H. . LIMITATION ON USE OF FUNDS FOR PROMOTION OF LEGALIZATION
OF CONTROLLED SUBSTANCES
a. Pursuant to Public Law(s) cited in paragraph b., below, contract
funds shall not be used to support activities that promote the
legalization of any drug or other substance included in schedule I of
the schedules of controlled substances established by section 202 of
the Controlled Substances Act (21 U.S.C. 812). This limitation shall
not apply when the contractor makes known to the contracting officer
that there is significant medical evidence of a therapeutic advantage
to the use of such drug or other substance or that federally sponsored
clinical trials are being conducted to determine therapeutic
advantage.
b. Public Law and Section No. Fiscal Year Period Covered
[applicable information to be included at award]
ARTICLE H. . OBTAINING AND DISSEMINATING BIOMEDICAL RESEARCH RESOURCES
Note to Offeror: The following Article will be included in all
Research & Development (R&D) Contracts and Non-R&D Contracts that
involve biomedical resources such as a repository or storage facility
of materials.
Unique research resources arising from NIH-funded research are to be
shared with the scientific research community. NIH provides guidance,
entitled, "Sharing Biomedical Research Resources: Principles and
Guidelines for Recipients of NIH Research Grants and Contracts,"
(Federal Register Notice, December 23, 1999 [64 FR 72090]), concerning
the appropriate terms for disseminating and acquiring these research
resources. This guidance, found at :
http://ott.od.nih.gov/NewPages/64FR72090.pdf. is intended to help
contractors ensure that the conditions they impose and accept on the
transfer of research tools will facilitate further biomedical
research, consistent with the requirements of the Bayh-Dole Act and
NIH funding policy.
Note: For the purposes of this Article, the terms, "research tools,"
"research materials," and "research resources" are used
interchangeably and have the same meaning.
Note to Offeror: The following subparagraph (a) below will be included
in contracts awarded on or after October 1, 2004 that involve
Biomedical Research of Model Organisms.
a. Sharing of Model Organisms for Biomedical Research
Note to Offeror: Applicable incorporation of plan, below, to be
determined during negotiations
The plan for sharing model organisms submitted by the contractor is acceptable.
OR
The contractor?s data sharing plan, dated__________, is hereby
incorporated by reference.
The contractor agrees to adhere to its plan and shall request prior
approval of the Contracting Officer for any changes in its plan.
ARTICLE H. . SHARING RESEARCH DATA
Note to Offeror: The following Article will be included in any
contract that will generate research data.
[The approved data sharing plan submitted by the resultant contractor
will either be incorporated by reference or identified as acceptable
herein.] The contractor agrees to adhere to its plan and shall request
prior approval of the Contracting Officer for any changes in its plan.
The NIH endorses the sharing of final research data to expedite the
translation of research results into knowledge, products, and
procedures to improve human health. This contract is expected to
generate research data that must be shared with the public and other
researchers. NIH's data sharing policy may be found at the following
Web site:
http://grants.nih.gov/grants/guide/notice-files/NOT-OD-03-032.html
NIH recognizes that data sharing may be complicated or limited, in
some cases, by institutional policies, local IRB rules, as well as
local, state and Federal laws and regulations, including the Privacy
Rule (see HHS-published documentation on the Privacy Rule at
http://www.hhs.gov/ocr/). The rights and privacy of people who
participate in NIH-funded research must be protected at all times;
thus, data intended for broader use should be free of identifiers that
would permit linkages to individual research participants and
variables that could lead to deductive disclosure of the identity of
individual subjects.
ARTICLE H. . POSSESSION USE AND TRANSFER OF SELECT BIOLOGICAL AGENTS OR TOXINS
Note to Offeror: The following Article will be included when contract
performance will involve possession, use or transfer of select
biological agents or toxins.
Work involving select biological agents or toxins shall not be
conducted under this contract until the contractor and any affected
subcontractor(s) are granted a certificate of registration or are
authorized to work with the applicable select agents.
For prime or subcontract awards to domestic institutions who possess,
use, and/or transfer Select Agents under this contract, the
institution must complete registration with the Centers for Disease
Control and Prevention (CDC), Department of Health and Human Services
(DHHS) or the Animal and Plant Health Inspection Services (APHIS),
U.S. Department of Agriculture (USDA), as applicable, before using NIH
funds for research involving Select Agents. No NIH funds can be used
for research involving Select Agents if the final registration
certificate is denied.
For prime or subcontract awards to foreign institutions who possess,
use, and/or transfer Select Agents under this contract, the
institution must provide information satisfactory to the NIH that a
process equivalent to that described in 42 CFR 73
(http://www.cdc.gov/od/sap/docs/42cfr73.pdf ) for U.S. institutions is
in place and will be administered on behalf of all Select Agent work
sponsored by these funds before using these funds for any work
directly involving the Select Agents. The contractor must provide
information addressing the following key elements appropriate for the
foreign institution: safety, security, training, procedures for
ensuring that only approved/appropriate individuals have access to the
Select Agents, and any applicable laws, regulations and policies
equivalent to 42 CFR 73. An NIAID-chaired committee of U.S. federal
employees (including representatives of NIH grants/contracts and
scientific program management, CDC , Department of Justice and other
federal intelligence agencies, and Department of State) will assess
the policies and procedures for comparability to the U.S. requirements
described in 42 CFR Part 73. When requested by the contracting
officer, the contractor should provide key information delineating any
laws, regulations, policies, and procedures applicable to the foreign
institution for the safe and secure possession, use, and transfer of
Select Agents. This includes concise summaries of safety, security,
and training plans, and applicable laws, regulations, and policies.
For the purpose of security risk assessments, the contractor must
provide the names of all individuals at the foreign institution who
will have access to the Select Agents and procedures for ensuring that
only approved and appropriate individuals have access to Select Agents
under the contract.
Listings of HHS select agents and toxins, biologic agents and toxins,
and overlap agents or toxins as well as information about the
registration process, can be obtained on the Select Agent Program Web
site at http://www.cdc.gov/od/sap/.
ARTICLE H. . HOTEL AND MOTEL FIRE SAFETY ACT OF 1990 (P.L. 101-391)
Note to Offeror: The following Article will be included in all
contracts in which the possibility of a federally funded, in whole or
in part, meeting, convention, conference or training seminar exists.
Pursuant to Public Law 101-391, no Federal funds may be used to
sponsor or fund in whole or in part a meeting, convention, conference
or training seminar that is conducted in, or that otherwise uses the
rooms, facilities, or services of a place of public accommodation that
do not meet the requirements of the fire prevention and control
guidelines a described in the Public Law. This restriction applies to
public accommodations both foreign an domestic.
Public accommodations that meet the requirements can be accessed at:
http://www.usfa.fema.gov/hotel/index.htm
ARTICLE H. . NIH POLICY ON ENHANCING PUBLIC ACCESS TO ARCHIVED
PUBLICATIONS RESULTING FROM NIH-FUNDED RESEARCH
Note to Offeror: The following Article will be included in all research contracts.
The Policy requests that beginning May 2, 2005, NIH-funded
investigators submit to the NIH National Library of Medicine?s (NLM)
PubMed Central (PMC) an electronic version of the author?s final
manuscript, upon acceptance for publication, resulting from research
supported in whole or in part with direct costs from NIH. NIH defines
the author?s final manuscript as the final version accepted for
journal publication, and includes all modifications from the
publishing peer review process. The PMC archive will preserve
permanently these manuscripts for use by the public, health care
providers, educators, scientists, and NIH. The Policy directs
electronic submissions to the NIH/NLM/PMC:
http://www.pubmedcentral.nih.gov.
Additional information is available at
http://grants.nih.gov/grants/guide/notice-files/NOT-OD-05-022.html. |
